Improving Parental Soothing by Video

NCT ID: NCT01826383

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-01-31

Brief Summary

This study sets out to compare the effectiveness of a parent pain management coaching video that is 5-minutes in length. The investigators will be comparing an active-video to a placebo-video of equal length (and identical formatting). Participants will be 6 or 18 month infants undergoing routine immunization. The investigators hypothesize the active video will result in a lowering of infant pain expressed post-immunization (3 minutes) and the increase in the parental use of distraction, physical comfort, and rocking.

Detailed Description

Our goal is to determine if a video instructing parents on the principles of soothing their infant following immunization will influence soothing behaviours exhibited by parents, and pain reactivity and regulation in infants. We plan to present parents of young infants (6 months) and older infants (18 months) with either a Treatment Video instructing them on the ABCD's (Assess Anxiety, Belly Breathe, Calm Close Cuddle, Distraction; Copyright R. Pillai Riddell) of pain management or a Placebo Video with neutral information. There is very minimal risk because our suggestions are based on what parents deemed 'sensitive' (in our ongoing longitudinal study) were doing naturally i.e., without any intervention in their day-to-day lives. Additionally, in a separate study, that already received ethics approval, parents viewed these videos without any negative side effects.

Participants will be adult parents from one of two clinics in the Greater Toronto Area who bring their infant in for a routine immunization (12 or 18 months). In our cohort study (where we simply videotape dyads in the clinic).

Parents will be asked to complete a brief questionnaire (Parent Information Sheet) entailing basic demographic information and preimmunization ratings of their worry about their infant's pain from the immunization. The parents will also be asked to complete the 18-item Brief Symptom Inventory (BSI-18) and the Negative Affect subscale (IBQ-R Very short form), in addition to demographic information. The parents will subsquently be asked to view a brief video (Treatment or Placebo Video) discussing the ABCD's of pain management described above. During the infant's routine immunization procedure the parents and infant will be videotaped for approximately 10 minutes, and the parent will be asked a few brief questions post immunization including ratings of their infant's pain from the immunization procedure and the helpfulness of the video.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Active Video

This is a five-minute video that coaches parents about how to soothe their infant post-immunization.

Group Type: EXPERIMENTAL

Active-Video

Intervention Type: BEHAVIORAL

This group will watch an active-video with pain management strategies for parents

Placebo Video

This is a video identical to that of the active video, except no specific instructions regarding how to soothe an infant post-immunization are given.

Group Type: PLACEBO_COMPARATOR

Placebo Video

Intervention Type: BEHAVIORAL

This group will watch a placebo-video describing immunization generally.

Interventions

Active-Video

This group will watch an active-video with pain management strategies for parents

Intervention Type: BEHAVIORAL

Placebo Video

This group will watch a placebo-video describing immunization generally.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Infants must be 6 or 18 months old receiving a routine immunization injection.
• Parents must be fluent in English.
• Only one child per family can be enrolled.

Exclusion Criteria

• No suspected developmental delays or chronic illnesses.
• Time spent in a Neonatal Intensive Care Unit.
• Born more than 3 weeks premature.

• Minimum Eligible Age: 5 Months
• Maximum Eligible Age: 20 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

York University

OTHER

Sponsor Role: lead

Responsible Party

RRiddell

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rebecca R Pillai Riddell, PhD

Role: PRINCIPAL_INVESTIGATOR

York University

Locations

Dr. Saul Greenberg's Pediatric Clinic

Toronto, Ontario, Canada

Dr. Hartley Garfield's Pediatric Clinic

Toronto, Ontario, Canada

Countries

Canada

References

Taddio A, Nulman I, Koren BS, Stevens B, Koren G. A revised measure of acute pain in infants. J Pain Symptom Manage. 1995 Aug;10(6):456-63. doi: 10.1016/0885-3924(95)00058-7.

Reference Type: BACKGROUND

PMID: 7561228 (View on PubMed)

Cohen, L.L., Bernard, R., McClellan, C., MacLaren, J. (2005). Assessing Medical Room Behaviour During Infants' Painful Procedures: The Measure of Adult and Infant Soothing and Distress (MAISD). Children's Health Care., 34, p. 81-94.

Reference Type: BACKGROUND

Other Identifiers

York HPRC 2013-004

Identifier Type: -

Identifier Source: org_study_id